Director, ADC CMC Sciences

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

Full time/dedicated responsibility for CMC leadership and project management for commercial and pipeline small molecule products Plays a key leadership role within S&T PPG group.

Responsibilities

• Lead cross-functional S&T product teams and represent the CMC team and/or S&T in interface with S&T leadership, other Operations functions, other AbbVie functions and external partners. Participate in or coordinate Governance efforts such as Product Performance Teams or gate reviews.
• Develop and maintain comprehensive project plans, budgets, timelines and strategy; technical projects at all stages of development are included, from phase II through commercial.
• Ensure sound, proactive technical ownership of the product, process and methods by the CMC team; facilitate the identification and resolution of technical issues and prioritization of efforts with strategic understanding of impact on Operations.
• Understand and present technical information regarding drug product and drug substance manufacturing processes and methods, process development/history and process characterization to management and regulatory agencies.
• Review submissions through registration of the product as well as post-approval life-cycle management. Serve as a peer/management reviewer for submissions.
• Represent assigned projects on the multidisciplinary Product Presentation and Device Strategy Team and collaborate with multidisciplinary team including R&D, RA, and Operations (MES, QA, sites, Supply Chain, purchasing, etc.)
• Manage multiple and/or complex projects at various stages of development, commercialization and commercial manufacturing.
• Develop new and less experienced CMC leads through sponsor/mentor relationships.
• Identify and promote best practices among S&T CMC leads.
• Establish and foster partnerships with key customers and counterpart functions to facilitate effective collaboration.

Qualifications

• Bachelor ’s Degree with 16+ years of relevant experience (CMC, small molecule manufacturing/development); Master’s Degree with 14+ years of relevant experience; PhD Degree with at least 12+ years of relevant experience.
• CMC development experience through IND and/or NDA/MAA.
  Experience leading multiple CMC project teams through IND and NDA/MAA preferred.
• Technical understanding and experience with small molecule products manufacturing, development, quality and analytics is required.
• Knowledge and experience with FDA and global regulatory requirements for CMC issues is required.
  Ability to influence internal and external experts on CMC regulatory issues, independently.
• Demonstrated excellence in writing, presentation, and overall communication.
• Demonstrated excellence in leading CMC project teams.
• Demonstrated ability to provide strategic direction for work groups, departments, etc.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

• This job is eligible to participate in our long-term incentive programs. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless anduntil paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

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